Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Reader, Be Wary: Sponsors Keep Most 'Complete Response' Letter Content Under Wraps, FDA Says

Executive Summary

Agency analysis provides rare portrait of 'complete response' letters while adding to the case for increased transparency.

You may also be interested in...



2017 Complete Response Letters: Fewer Than 2016, Still More Than Years Past

US FDA's complete response letters dropped from 41 in 2016 to 30 in 2017; quality issues as share of total letters continued to climb.

Amgen's Reticence On Parsabiv Complete Response Letter Revives Transparency Issue

But Amgen is in good company when it comes to companies that choose not to disclose the contents of complete response letters, data from the Pink Sheet's FDA Performance Tracker show. Merck especially holds such information close.

Talking It Out: Perseverance Helps Sponsors Overcome Disagreements With FDA

Some of the most valuable lessons learned out of Pharmaceutical Approvals Monthly’s Drug Review Profile series involve getting FDA to be flexible about what kind of clinical data it requires.

Related Content

Topics

UsernamePublicRestriction

Register

PS056968

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel